actemra

Actemra (tocilizumab) reduces the effects of a substance in the body that can cause inflammation.

Actemra is used to treat moderate to severe rheumatoid arthritis in adults. It is sometimes given together with other arthritis medicines.

Actemra is also used to treat systemic juvenile idiopathic arthritis or "Still disease") in children who are at least 2 years old. It is sometimes given together with methotrexate (Rheumatrex, Trexall).

Actemra is usually given after other medications have been tried without successful treatment of symptoms.

Important information

Serious and sometimes fatal infections may occur during treatment with Actemra. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, body aches, flu symptoms, cough, sweating, feeling short of breath, diarrhea, weight loss, sores on your skin, painful urination, or feeling very tired.

Before you start treatment with Actemra, your doctor may perform tests to make sure you do not have tuberculosis or other infections. While using Actemra, you may need frequent medical tests.

Before receiving Actemra

You should not use Actemra if you are allergic to tocilizumab.

Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where certain infections are common (Ohio River Valley, Mississippi River Valley, and the Southwest).

To make sure Actemra is safe for you, tell your doctor if you have:

• an active or recent infection (such as herpes, pneumonia, or yeast infection);

• signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood;

• liver disease;

• diverticulitis, stomach ulcer, or a history of stomach or intestinal bleeding;

• diabetes;

• HIV or AIDS;

• a weak immune system;

• hepatitis B (or if you are a carrier of the virus);

• a nerve-muscle disease such as multiple sclerosis;

• a history of cancer; or

• if you are scheduled to receive any vaccines.

Treatment with Actemra may increase your risk of developing certain types of cancer. Talk to your doctor about your specific risk.

FDA pregnancy category C. It is not known whether Actemra will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of tocilizumab on the baby.

It is not known whether tocilizumab passes into breast milk. You should not breast-feed while you are using Actemra.

How is Actemra given?

Before you start treatment with Actemra, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Actemra is injected into a vein through an IV. A healthcare provider will give you this type of injection.

Actemra is sometimes injected under the skin. You may be shown how to use this type of injection at home using a prefilled syringe. Do not self inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Actemra is usually given every 2 to 4 weeks. Follow your doctor"s instructions.

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Do not use Actemra if it has changed colors or has particles in it. Call your pharmacist for new medication.

Each prefilled syringe is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store the prefilled syringes in their original container in a refrigerator. Protect from moisture and light. Do not freeze. Throw away any prefilled syringes not used before the expiration date on the medicine label.

Actemra can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

If you need surgery, tell the surgeon ahead of time that you are using Actemra. You may need to stop using the medicine for a short time.

Actemra can have long lasting effects on your body. You may need certain medical tests every 6 months after you stop using this medication.

If you have ever had hepatitis B, Actemra can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

You may be treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor"s advice.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using Actemra, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Actemra side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Actemra : hives; chest pain, difficulty breathing, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Actemra. Call your doctor right away if you have signs of infection such as:

• fever, chills, muscle pain, night sweats, mouth sores, white patches in your throat, weight loss, feeling very tired;

• fast heart rate, rapid breathing, chest pain, wheezing, cough, shortness of breath;

• redness or swelling under your skin, painful skin sores, blistering skin rash with burning or tingly feeling;

• watery diarrhea, pain or burning when you urinate;

• blurred vision, bone pain, confusion, headache, nausea, swollen glands; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Also call your doctor at once if you have:

• severe stomach cramps, bloating, diarrhea or constipation;

• black, bloody, or tarry stools; or

• coughing up blood or vomit that looks like coffee grounds.

Common Actemra side effects may include:

• runny or stuffy nose, sinus pain, sore throat;

• headache, dizziness;

• high blood pressure (blurred vision, buzzing in your ears, anxiety, confusion, shortness of breath, uneven heartbeats).; or

• pain, swelling, burning, or irritation around the IV needle or where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Actemra?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Actemra, especially:

• any other medicines to treat rheumatoid arthritis, such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, or rituximab.

This list is not complete and many other drugs can interact with tocilizumab. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you. Not all possible interactions are listed in this medication guide.